Active clinical trials for "Myocardial Infarction"

Proposed novel solution for high-risk heart disease Overall in-hospital mortality among ST elevation myocardial infarction (STEMI) patients is 3-4%, but >50% patients experiencing cardiogenic shock (CS) secondary to STEMI die in the hospital. Evidence suggests early diagnosis and treatment of CS results in improved outcomes, albeit, there is no tool to diagnose CS reliably in a timely fashion in STEMI patients through the continuous monitoring. We hypothesize that bioimpedance-derived hemodynamic measures obtained using the Non-Invasive Cardiac System (NICaS) can facilitate early detection of CS, predict outcomes, and revolutionize the STEMI patient management. The objectives of SHOCk-NICaS study in STEMI patients are to: a) identify the CS early, using NICaS derived cardiac index of ≤1.8L/min/m2 or ≤2.2L/min/m2 with the use of vasopressor and/or inotropes, and compare it with the incidence of CS based upon lactate level ≥2mmol/L, and systolic blood pressure <90mmHg; b): determine the impact of primary percutaneous coronary intervention (PPCI), using NICaS derived hemodynamic measures (stroke volume, cardiac index, cardiac power index, etc), by comparing pre- and post-angioplasty; and c) identify outcome-associated hemodynamic markers. A composite score of death during hospital stay, prolonged hospitalization due to heart failure (>72hrs), and use of inotropic or mechanical circulation support is a primary outcome. Methodology This is a multi-center, double-blind, prospective cohort study enrolling STEMI patients aged ≥18years visiting at 4 cardiac centers (St Boniface, St. Michael's, McGill University Hospital). Using validated NICaS protocol, hemodynamic parameters will be recorded at baseline, during the PPCI procedure, and within 24-hour post PPCI without altering the standard care. Statistical analysis: Baseline data will be reported as mean±SD or median±interquartile range. The outcomes will be assessed using multivariable logistic regression. We will analyze the impact of age, sex, gender, and ethnicity on hemodynamic measures. The targeted 500 patients will ensure a margin of error of 5% at a 95% CI. So far recruited 76 STEMI patients mark the study feasibility. Significance This novel study in high-risk STEMI patients will provide a promising cost-effective, rapid, and non-invasive tool to identify CS early; a prompt intervention may curtail the high morbidity and mortality. The meticulously designed pragmatic study outcomes may revolutionize STEMI patient management.

The HIV/HEART Aging study (HIVH) is an ongoing, prospective, multicentre trial that was conducted to assess the incidence, the prevalence and the clinical course of cardiovascular diseases (CVD) in HIV-infected patients. The study population includes outpatients from specialized HIV-care units of the German Ruhr region, who were at least 18 years of age, were known to have a HIV-infection and exhibited a stable disease status within 4 weeks before inclusion into the trial. From March 2004 (Pilot phase) to October 2022 (15 year Follow-up) 1858 HIV+ patients were recruited in a consecutive manner. The standardised examinations included a targeted assessment of medical history and physical examination. Blood was drawn for comprehensive laboratory tests including HIV specific parameters (CD4 cell count, HIV-1 RNA levels) and cardiovascular items (lipid concentrations, BNP values and renal parameters). Furthermore, non-invasive tests were performed during the initial visit, including additional heart rate and blood pressure measurements, electrocardiogram (ECGs) and transthoracic echocardiography (TTE). Examinations were completed in accordance with previously defined standard operating procedures. CVD were defined as coronary, cerebrovascular, peripheral arterial disease, heart failure or cardiac vitium.

Myocardial infarction (MI) is a leading cause of death in developed countries, including Sweden. Standard treatment for patients after MI includes exercise-based cardiac rehabilitation which contributes to improved cardiovascular function and reduces the risk of hospital readmissions, new cardiovascular events and mortality. Thermotherapy may also have beneficial effects on cardiovascular disease by a reduction in inflammatory status and improved metabolism and vascular function. Given the well-documented effects of exercise training on cardiac rehabilitation and recent evidence that thermotherapy may improve cardiovascular function, we wish to investigate the effect of exercise combined with hot water immersion (HWI) in cardiac rehabilitation post-MI. This is a single-centre, randomized controlled clinical trial in patients with recent MI. Our aim is to investigate whether exercise training combined with HWI improves inflammatory and metabolic status, cardiovascular function as well as psychological well-being, compared with exercise training alone. Patients will be randomized 1:1 to an 8 week intervention with exercise training 2 times per week followed by 15 minutes of hot water immersion, or to a control group with exercise training alone. The primary endpoint is changes in the inflammatory marker interleukin (IL-) 6 between groups at 8 weeks. Secondary endpoints include other biomarkers of inflammation, metabolism, effects on cardiovascular function and psychological benefits. Secondary prevention after MI has improved during the last decades but readmissions and death following acute MI remain large health challenges. If HWI in addition to standard cardiac rehabilitation can lower inflammation more than standard therapy alone, and improve metabolic, cardiovascular and psychological status, it could be a cost-effective and safe complementary strategy for secondary prevention after MI, particularly for those with limited exercise capability.

The investigators aim to show the feasibility and medicoeconomic impact of implementing a clinical screening and response system for the early detection of perioperative cardiac complications in high-risk patients. Specifically, the investigators aim to: 1) evaluate the feasibility of implementation of a PMI-screening; 2) evaluate the medicoeconomic impact of implementing a PMI-screening; 3) identify barriers to implementation; 4) generate data for a future randomized controlled trial on outcomes by exploring opportunities to improve care following PMI, the occurrence and timing of major adverse cardiac events (MACE), and the treatment effect associated with PMI-screening.

The goal of this phase 3, randomized, double-blind, placebo-controlled clinical trial is to explore the safety and efficacy of dutogliptin administered subcutaneously (SC) in co-administration with filgrastim in adult patients with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI). The primary objective is to evaluate the efficacy of dutogliptin compared with placebo in STEMI patients within 180 days of randomization measured by the time of first occurrence of a composite endpoint of cardiovascular (CV) death and worsening heart failure (HF) within 180 days. Participants will receive dutogliptin twice daily subcutaneously (SC) for 14 days and filgrastim (SC) daily for 5 days or placebo.

This investigational device exemption (IDE) study is to assess the safety and effectiveness of the Shockwave Coronary Intravascular Lithotripsy (IVL) System with the Shockwave C2+ 2Hz Coronary IVL Catheter to treat de novo, calcified, stenotic, coronary lesions prior to stenting.

The goal of this observational study is to learn about in STEMI with Primary PCI Patients. The main questions it aims to answer are: To determine the value of AMR in predicting the long-term clinical prognosis of patients with STEMI after PPCI, and to find the best cut-off value. Analyze the factors of PPCI affecting AMR and explore the effective measures of PPCI microcirculation protection. Radiographic images of STEMI receiving primary PCI treatment in several chest pain centers in China will be included. The last image of the infarct-related vessel will be used as a target to calculate its AMR. The relationship between AMR and long-term clinical prognosis was analyzed.

The PRESC1SE-MI study compares two algorithms for triage of patients presenting with chest pain and symptoms of heart attack (myocardial infarction) to the emergency department. Both algorithms are recommended by the European Society of Cardiology: the 0/3-hour algorithm and the 0/1-hour algorithm. Currently, most emergency departments worldwide use the 0/3-hour troponin algorithm. Cardiac troponin (cTn) is a heart-specific biomarker which indicates damage of the heart muscle and which increases after a heart attack. In the 0/3-hour algorithm, the amount of troponin in the bloodstream is measured with a high-sensitivity assay at admission and 3 hours thereafter. Likewise, the 0/1-hour algorithm means that the blood sample in which the troponin is measured is collected at admission and 1 hour later. Since recent clinical studies suggest that the 0/1-hour algorithm is superior to the 0/3-hour algorithm, many hospitals consider switching to the 0/1-hour algorithm. The aim of this study is to assess how feasible the time-saving 0/1-hour algorithm would be in reality and whether it provides the same accuracy and safety in the diagnosis of myocardial infarction as the current practice the 0/3-hour algorithm.

Despite the relative safety of PCI with new generation stents, peri-PCI thrombotic complications, including myocardial infarction and myocardial injury, are common in elective PCI, occurring in up to 30% of patients. Importantly, these events are associated with poor prognosis. The risk of peri-PCI myocardial infarction/myocardial injury has been in part attributed to HPR. The aim of this study is to prospectively validate the accuracy of the ABCD-GENE score in identifying stable CAD patients undergoing elective PCI treated with standard of care clopidogrel who are at risk of peri-PCI myocardial infarction/myocardial injury. This investigation will be a prospective cohort study conducted in a population of patients (n=500) with stable CAD undergoing elective PCI treated with standard of care clopidogrel. By integrating genetic data with clinical variables, patients will be stratified into 2 cohorts based on their ABCD-GENE score (using a cut-off of 10). Assessments to define HPR status and myocardial infarction/myocardial injury will be performed post-PCI.

The purpose of this study is to learn if a voice analysis smartphone app which detects anxiety and depression could be used along with cardiac rehabilitation to improve results compared to cardiac rehabilitation alone.